Non Elective Vulnerable Elderly Radiotherapy (NEVER)

Azienda Ospedaliero Universitaria Policlinico Modena

Status: Enrolling

Conditions: Squamous Cell Carcinoma of Head and Neck

Treatments: Radiation: Non elective radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04832555

NEVER

Details and patient eligibility

About

To evaluate whether patients defined "non-fit for curative non-surgical radio-chemotherapy" and therefore treated with RT alone addressed only to non-elective sites of disease, could obtain a non-inferior loco-regional control compared to similar historical cohorts.

Full description

The current standard approach for head and neck malignancies cannot be considered the gold standard for elderly patients, except in carefully selected cases. Given the relevance of this population, scientific societies also suggest to propose prospective studies for this subset of frail patients (European Organization for Research and treatment of cancer (EORTC), European Society for Medical oncology (ESMO)). In addition, it is necessary to collect data on specific categories, which are as homogeneous as possible. Therefore, the purpose of this study is to evaluate efficacy and safety of a tailored RT approach administered with a curative intent in a subset of frails elderly patients not candidates neither to standard concurrent RT-CT / RT-cetuximab nor to palliative treatment/best supportive care.

Enrollment: 100 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• locally advanced non-metastatic HNSCC patients older than 70 years
• Primary tumor clinically and radiologically detectable and measurable (staging according to ed. TNM VII and also VIII.
• patients defined by the tumor board (ENT, Oncologist, Radiotherapist, Nutritionist) as 1) not eligibles for RTCT / RT-cetuximab treatment 2) not amenable to radical surgery and 3) not candidates for treatments with palliative intent/best supportive care
• Availability of staging with CT/PET for distant metastasis and CT/MRI for primary tumor
• Karnofsky performance status (KPS) ≥60/100
• Oropharynx , Hypopharynx and Larynx, Oral cavity: stage III and IV and Unknown primitive P16-POSITIVE

Exclusion criteria

• Age less than 70 years

  • Staging exams done 45 days before the date of the beginning of the treatment
  • Subsites: nasopharynx, salivary glands, paranasal sinuses. Metastatic disease
  • Gross total excision
  • All subsites concerned if N3.
  • Squamous cell neoplasms of the glottic larynx T1-T2 N0.
  • Unknown primary HPV negative or EBV positive.
  • Presence of distant metastases or sub-clavicular lymphadenopathies.
  • Previous surgery on T and/or N except diagnostic tonsillectomy.
  • 3D-conformational radiotherapy technique

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Open: non elective irradiation

Experimental group

Description:

Patients within inclusion criteria will be enrolled in the experimental treatment: a radiation therapy addressed to non elective site of disease and with a simultaneous integrated boost

Treatment:

Radiation: Non elective radiotherapy